Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000920
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
Fortovase Saquinavir Given With Low-Dose Ritonavir Zidovudine and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Trial of the Safety and Pharmacokinetics of Fortovase Saquinavir-SGC Co-Administered With Low Dose Ritonavir RTV ZDV and 3TC in HIV Seropositive Pregnant Women During Gestation and Postpartum and in Their Infants Post-Maternal Dosing
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if it is safe to give saquinavir-SGC SQV combined with low-dose ritonavir RTV plus zidovudine ZDV and lamivudine 3TC to HIV-positive pregnant women and to see if it is safe to give 3TC and ZDV to their newborns Another purpose is to see what levels of SQV low-dose RTV ZDV and 3TC are found in mothers and what levels of ZDV and 3TC are seen in newborns Another purpose of this study is to see whether SQV passes from mother to newborn and if it passes at a level that is safe for the newborn
Although ZDV has been able to reduce the rate of transmission of HIV from mother to child it may be possible to reduce it further by using a combination of anti-HIV drugs This study adds SQV a protease inhibitor PI with RTV another PI and 3TC a reverse transcriptase inhibitor to the mothers ZDV regimen
Although ZDV has been able to reduce the rate of transmission of HIV from mother to child it may be possible to reduce it further by using a combination of anti-HIV drugs This study adds SQV a protease inhibitor PI with RTV another PI and 3TC a reverse transcriptase inhibitor to the mothers ZDV regimen
Detailed Description:
Although administration of ZDV to mother-infant pairs has dramatically reduced perinatal HIV infection the goal is to reduce it further to less than 2 In order to achieve this combination strategies need to be developed for 2 purposes 1 to reduce the perinatal transmission rate to goal levels and 2 to provide other combination therapies for HIV-infected mothers whose virus has become resistant to ZDV who have a very high viral load or who have previously transmitted HIV while on ZDV This study adds 3TC another reverse transcriptase inhibitor and SQV a protease inhibitor PI AS PER AMENDMENT 081500 with low-dose RTV another PI to the mothers ZDV regimen
During the antepartum period mothers receive SQV with AS PER AMENDMENT 081500 low-dose RTV plus ZDV and 3TC At onset of active labor mothers receive loading doses of each of the study drugs then receive study drugs for 12 weeks postpartum on the same schedule as during the antenatal period Within 12 hours of delivery infants begin receiving 3TC and ZDV and continue until 6 weeks of age Mothers are followed until 12 weeks postpartum and babies are followed until 6 months of age AS PER AMENDMENT 020999 For maternal dosing 1 Combivir tablet containing 3TC and ZDV may be administered in place of the individual agents 3TC and ZDV Patients who prematurely discontinue study treatment should continue to be followed for the duration of the study
During the antepartum period mothers receive SQV with AS PER AMENDMENT 081500 low-dose RTV plus ZDV and 3TC At onset of active labor mothers receive loading doses of each of the study drugs then receive study drugs for 12 weeks postpartum on the same schedule as during the antenatal period Within 12 hours of delivery infants begin receiving 3TC and ZDV and continue until 6 weeks of age Mothers are followed until 12 weeks postpartum and babies are followed until 6 months of age AS PER AMENDMENT 020999 For maternal dosing 1 Combivir tablet containing 3TC and ZDV may be administered in place of the individual agents 3TC and ZDV Patients who prematurely discontinue study treatment should continue to be followed for the duration of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PACTG 386 | Registry Identifier | DAIDS ES | None |
| 11345 | REGISTRY | None | None |